Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02105701 | Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068) | PHASE3 | COMPLETED | 420 | — | — | Jun 5, 2014 | Jun 19, 2015 | Feb 5, 2021 | - | — |
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Grazoprevir + Elbasvir 12 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg fixed-dose combination (FDC) tablets once daily (q.d.) by mouth for 12 weeks. |
| Grazoprevir + Elbasvir + RBV 12 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules twice daily (b.i.d.) by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks. |
| Grazoprevir + Elbasvir 16 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks. |
| Grazoprevir + Elbasvir + RBV 16 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Grazoprevir + Elbasvir | DRUG | FDC tablet containing grazoprevir 100 mg and elbasvir 50 mg. |
| Ribavirin | DRUG | 200 mg capsule |
Inclusion Criteria: * Documented chronic HCV GT1, GT4, or GT6 with no evidence of non-typable or mixed genotype infection (positive for anti-HCV antibody, HCV ribonucleic acid \[RNA\], or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results) * Cirrho...